BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD TENSION FREE BLADDER SLING

    MDR report key: 3111703 · Received May 8, 2013

    Report

    Report Number
    MW5030132
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 11, 2013
    Report Date
    May 8, 2013
    Manufacturer
    BARD MEDICAL DIVISION
    Product Code
    PAG
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD BARD TRANSVAGINAL MESH AND BLADDER SLING IMPLANTED IN (B)(6) 2007, THEN HAD CONTINUOUS PROBLEMS WITH THE VAGINAL MESH IE: PAIN DURING INTERCOURSE AND EROSION OF MESH IN VAGINA. THEN HAD CONTINUAL UTI'S FOR 7 YRS AND NO ONE COULD EVER FIND OUT WHAT WAS CAUSING THE UTI'S SO I THEN WENT TO A UROLOGIST AND THEY DID A TEST TO LOOK INSIDE MY URETHRA AND FOUND THAT THE BARD BLADDER SLING HAD ERODED INTO MY URETHRA. I HAD SURGERY ON MY URETHRA AND HAD BLADDER SLING REMOVED ON (B)(6) 2013. THEN I HAD A VOIDING CYSTOGRAM TO SEE IF THE ISSUE HAD BEEN FIXED. FOUND OUT ON (B)(6) 2013 THAT THE MESH HAD CAUSED A FISTULA INTO THE VAGINA. I WILL HAVE FURTHER SURGERIES TO PUT A NEW SLING BACK IN AND TO REPAIR AGAIN MY URETHRA DAMAGE. REASON FOR USE: POP; URINARY INCONTINENCE AND VAGINAL RECONSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200166 BARD TENSION FREE BLADDER SLING BARD PAG BARD MEDICAL DIVISION
    200167 BARD TRANSVAGINAL MESH BARD FTL BARD MEDICAL DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization BARD TENSION FREE TRANSVAGINAL MESH| BARD BLADDER SLING MESH